The glucose meters are being recalled because at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Blood Glucose Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result.
For example For a blood glucose value of 1066 mg/dL, the meter will display and store a value of42 mg/dL (1066 mg/dL – 1024 mg/dL = 42 mg/dL).
Blood glucose levels at 1024 mg/dL and above are very rare. However, if high blood glucose levels of 1024 mg/dL and above occur, they are a serious health risk that requires immediate medical attention.
The FreeStyle InsuLinx Blood Glucose Meters were distributed from April 18, 2012 through April 1, 2013. Other FreeStyle meters have not been affected by this recall.
The company recommends that patients and care givers using the FreeStyle InsuLinx Meter should immediately take one of the following actions to address this issue with your meter:
- Access a software update to install on your meter to resolve the issue at: www.freestyleinsulinx.com/swupdate. The software update will allow you to maintain settings and historical data on your meter.
- Contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to expedite return and replacement of your FreeStyle InsuLinx meter at no charge. Replacements are available, and Abbott will send a meter to you immediately upon request.
Healthcare professionals who have FreeStyle InsuLinx Blood Glucose Monitoring Kits are advised to immediately discontinue dispensing them to your patients, and to arrange for product return and replacement, call Abbott Diabetes Care customer service at 1-866-723-2697.